Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Recalled by Tornier, Inc Due to Two lots have been swapped thus have the...

Date: May 28, 2021
Company: Tornier, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tornier, Inc directly.

Affected Products

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

Quantity: 20

Why Was This Recalled?

Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

Where Was This Sold?

This product was distributed to 2 states: IL, TX

Affected (2 states)Not affected

About Tornier, Inc

Tornier, Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report